Restarting oral anticoagulant therapy after major bleeding in atrial fibrillation: A systematic review and meta-analysis.

ABSTRACT

BACKGROUND: Use of oral anticoagulant (OAC) therapy in atrial fibrillation (AF) is associated with an inherited risk of bleeding. Benefits and risks of OAC restarting after a major bleeding are still uncertain. We aimed to assess effectiveness and safety of restarting OAC in AF patients after a major bleeding event. METHODS: We performed a systematic review and meta-analysis of all studies reporting data about AF patients that sustained a major bleeding, reporting data on restarting or not restarting OAC therapy. RESULTS: A total of seven studies were included, involving 5685 patients. No significant difference was found in "any stroke" occurrence between OAC restarters and non-restarters (odds ratio [OR] 0.75, 95% confidence interval [CI] 0.37-1.51), with a significant 46% relative risk reduction (RRR) (p < 0.00001) for "any thromboembolism" in OAC restarters, with consistent results when the index bleeding event was an intracranial or gastrointestinal bleeding. A significantly higher risk of recurrent major bleeding was seen (OR 1.85, 95% CI 1.48-2.30), but no difference in risk for recurrence of index event. OAC restarters had a 10.8% absolute risk reduction for all-cause death (OR 0.38, 95% CI 0.24-0.60); p < 0.00001). Net clinical benefit (NCB) analysis demonstrated that restarting OAC therapy after a major bleeding was significantly associated with a clinical advantage (NCB 0.11, 95% CI 0.09-0.14; p < 0.001). CONCLUSIONS: Restarting OAC therapy after a major bleeding event in AF was associated with a positive clinical benefit when compared to non-restarting OAC, with a significant reduction in any thromboembolism and all-cause mortality.